Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management

Not Applicable

Completed

• Conditions: Pleural Effusion, Malignant
• Interventions: Device: Chest Drain Insertion and Talc Pleurodesis; Device: Indwelling Pleural Catheter Insertion and Talc Pleurodesis

• Registration Number: NCT02517749
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

This is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. Patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. Patients will be followed up for 3 months post intervention

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-07
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Diagnosis of malignant pleural effusion
2. WHO performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage
3. Expected survival greater than 3 months

Exclusion Criteria

1. Age less than 18 years old

2. Pregnant or lactating

3. Known allergy to Talc or Lignocaine

4. Lack of symptomatic relief from effusion drainage

5. At least twice weekly drainage cannot be undertaken

6. Lymphoma or small cell carcinoma except*:

   1. Failure of chemotherapy
   2. Deemed for palliative management

7. Non malignant effusions

8. Loculated pleural effusion

9. Unable to provide written informed consent to trial participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Usual Care Group	Chest Drain Insertion and Talc Pleurodesis	Patients in this group will be managed as per the British Thoracic Society guideline for management of malignant pleural effusions. They will undergo chest tube insertion and undergo Talc pleurodesis with 4g of SteriTalc
Indwelling Pleural Catheter Group	Indwelling Pleural Catheter Insertion and Talc Pleurodesis	Patients in this group will undergo Indwelling Pleural Catheter (IPC) insertion. This will be inserted as per standard practice. They will undergo Talc pleurodesis via the IPC with 4g SteriTalc

Primary Outcome Measures

Name	Time	Method
Global health-related quality of life	30 days	Global health related quality of life as measured by EORTC QLQ-C30

Secondary Outcome Measures

Name	Time	Method
Global health-related quality of life	60 and 90 days
Complication rate	Day 7, 14, 30, 60 and 90	Clinical review and adverse event documentation
Pleurodesis failure rate	30, 60 and 90 days	Subsequent pleural intervention required on same side as pleurodesis; Chest X-ray opacification greater than 25% on side of intervention
Improvement in symptoms of pain and breathlessness	30, 60 and 90 days	Medical Research Council (MRC) dyspnoea scale 100mm Visual Analog Scale for pain and breathlessness

Trial Locations

Locations (1)

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom